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Aia-Pack Cort Assay

by Tosoh Medics, Inc.

510(k) K954591

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK954591 Date15 Dec 1995ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2094-2018 FDA Class II initiated 5 Mar 2018

    Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JFT
Device Class
Class II
Regulation
21 CFR Part 862.1205
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Aia-Pack Cort Assay is a fluorometric device used for the quantitative measurement of cortisol in human serum, heparinized plasma, or EDTA plasma. It is designed for in-vitro diagnostic use on Tosoh AIA system analyzers.

This device is supplied for use on Tosoh AIA-Immunoassay platforms and is subject to FDA 510(k) clearance. It is classified under regulation number 862.1205 within the clinical chemistry medical specialty.

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Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of the Aia-Pack Cort Assay?

    This device is an in-vitro diagnostic tool designed for the quantitative measurement of cortisol levels in human serum, heparinized plasma, or EDTA plasma samples.

  • Which equipment is required to run this assay?

    The Aia-Pack Cort Assay is specifically engineered for use on Tosoh AIA-Immunoassay platform analyzers to ensure accurate and consistent fluorometric measurement.

  • What is the regulatory status of this cortisol assay?

    The Aia-Pack Cort Assay has received FDA 510(k) clearance, confirming it is substantially equivalent to predicate devices for its intended clinical chemistry applications.